NDC 71770-120

Siklos

Hydroxyurea

Siklos is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Medunik. The primary component is Hydroxyurea.

Product ID71770-120_39756145-7b62-406e-bbe8-2771276fe543
NDC71770-120
Product TypeHuman Prescription Drug
Proprietary NameSiklos
Generic NameHydroxyurea
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-04-15
Marketing CategoryNDA / NDA
Application NumberNDA208843
Labeler NameMedunik
Substance NameHYDROXYUREA
Active Ingredient Strength1000 mg/1
Pharm ClassesAntimetabolite [EPC], Urea [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71770-120-30

1 BOTTLE in 1 CARTON (71770-120-30) > 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2018-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71770-120-30 [71770012030]

Siklos TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208843
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-06

Drug Details

Active Ingredients

IngredientStrength
HYDROXYUREA1000 mg/1

OpenFDA Data

SPL SET ID:76957c0d-0f98-4376-bb06-eee651adc09d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1999308
  • 1999316
  • 283475
  • 1999314
  • Pharmacological Class

    • Antimetabolite [EPC]
    • Urea [CS]
    • Antimetabolite [EPC]
    • Urea [CS]

    NDC Crossover Matching brand name "Siklos" or generic name "Hydroxyurea"

    NDCBrand NameGeneric Name
    71770-100SiklosSiklos
    71770-120SiklosSiklos
    71770-105SiklosSiklos
    0003-6335DROXIAHYDROXYUREA
    0003-6336DROXIAHYDROXYUREA
    0003-6337DROXIAHYDROXYUREA
    0003-0830HYDREAHYDROXYUREA
    0093-0882HYDROXYUREAHydroxyurea
    0555-0882HYDROXYUREAHydroxyurea
    0904-6939HydroxyureaHydroxyurea
    10135-702HydroxyureaHydroxyurea
    24535-0831HydroxyureaHydroxyurea
    42291-321HYDROXYUREAHydroxyurea
    49884-724HydroxyureaHydroxyurea
    55154-3554HydroxyureaHydroxyurea
    55154-7143HydroxyureaHydroxyurea

    Trademark Results [Siklos]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SIKLOS
    SIKLOS
    86229715 4887561 Live/Registered
    ADDMEDICA
    2014-03-24

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